参与者多样性和包容性试验设计:加拿大随机临床试验的元流行病学研究
Shannon M Ruzycki1, Kirstie C Lithgow2, Claire Song3
1Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Journal of clinical epidemiology
|December 10, 2025
概括
加拿大临床试验显示女性和女性参与者的代表性很好,但没有报告其他人口统计数据. 为了准确的代表性,需要改善种族,民族和性别认同的报告.
科学领域:
- 临床试验 临床试验
- 健康 公平 卫生 公平
- 人口统计研究 人口统计研究
背景情况:
- 临床试验对于评估医疗干预至关重要.
- 参与者的人口统计学影响治疗的有效性和安全性.
- 在试验中不同群体的代表性不足会导致健康差异.
研究的目的:
- 描述加拿大随机临床试验 (RCT) 参与者的人口和社会身份.
- 评估加拿大RCT参与者特征报告的完整性.
主要方法:
- 一项超流行病学研究分析了在2010-2019年期间在ClinicalTrials.gov注册的118个已发表的2期和3期RCT.
- 用PROGRESS-PLUS等框架提取参与者的人口统计和社会身份数据.
主要成果:
- 包括17,387名参与者;89%的人报告了性别,但只有10.2%的人报告了性别.
- 报告了女性 (63.6%) 和男性 (32.8%) 参与者,但性别多元参与者没有.
- 只有23.7%的参与者报告了种族/种族,其中72.0%被确定为白人,2.7%为黑人,0.2%为土著.
结论:
- 加拿大的RCT显示,女性和女性参与者的代表性令人鼓舞.
- 性别,种族和民族的显著低报告限制了对参与者多样性的理解.
- 加强报告标准是必要的,以确保试验结果可以对所有人群进行概括.
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